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UC San Francisco (UCSF)

Clinical Research Coordinator

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Description

The Clinical Research Coordinator will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Clinical Research Supervisor and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.

Incumbent’s duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, assist with training of Assistant CRCs and other team members, and assist Clinical Research Supervisor and/or PI with oversight of other research staff; enter study data into databases and checked data entry for quality assurance, participate in project team meetings, evaluate eligibility criteria for research participation for report to study PI, enroll/register/schedule/retain study participants, collection of clinical data and shipment of biological samples, ensure participants are evaluated according to study protocol, manage Investigator’s protocols in the Committee on Human Research online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned.

Department Overview:

The Clinical Research Coordinator will work on studies evaluating factors contributing to accelerated cognitive and functional decline in older adults with Major Depressive Disorder and other psychiatric illnesses. Factors to be evaluated include genetic risk factors, MRI measures of cortical volume loss, and Positron Emission Tomography measures of amyloid and tau deposition. Outcome measures include clinical measures of cognition, disability, and psychiatric status as well as measures of cognitive, psychiatric, and functional status obtained remotely and unsupervised through online data collection.

The UCSF Department of Psychiatry and Behavioral Sciences (DPBS) is a leader in advancing mental health care, research, and education. The Department is among the nation’s foremost resources in the field of child, adolescent and adult mental health. Joining UCSF DPBS provides an opportunity to work alongside world-renowned experts in psychiatry, psychology, neuroscience, and behavioral sciences. Psychiatry faculty members are recognized for their leadership roles in state-of-the-art, comprehensive and compassionate patient care, pioneering research, excellence in training the next generation of leaders, advancing public policy to advance mental health, and commitment to diversity. The department is committed to improving mental health across diverse populations and fostering innovation in treatment, prevention, and research.

%

of time (Nothing less than 5%)

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

40

YES

Study Coordination and Data Collection

  • Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects.
  • Schedule subjects for study visits; meet with them to administer questionnaires, collect medical history and perform study procedures.
  • Maintain rapport and relationships with subjects to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments, and become their intermediary; discuss study outcomes with providers to ensure continuity of care.
  • Obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure.
  • Oversee subject reimbursement; work to resolve discrepancies and issues.
  • Work with staff to ensure procedures are completed, specimens properly stored, and required data collected at visits; and ensure correct shipping and labeling measures.
  • Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups.
  • Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies.
  • Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.

20

YES

Data management and reporting of results

  • Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner.
  • Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed.
  • Create and maintain comprehensive data sets as requested by the CRC Supervisor and/or PI.
  • Maintain data collection forms for effective data collection, entry, and analysis.
  • Perform queries and analysis in databases.
  • Work with Supervisor to maintain complete and accurate data in the study database; analyze the data as they become available.

5[MP1] [RR2]

YES

Staff Meetings and training

  • Attend and actively participate in regular team meetings
  • Help train staff and other team members on new research protocols, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, and other procedures.
  • Oversee data integrity; initiate assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management.
  • Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry.
  • Implement and maintain periodic quality control procedures
  • Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies.
  • Modify data collection instruments
  • Help schedule staff time and coordinate staff schedules.
  • Maintain subject tracking systems.
  • Arrange the exchange of and transport of specimens with collaborating Investigators and staff.
  • Oversee the incoming data interpreted from samples and ensure that it is utilized correctly for analysis and publications.
  • Ensure integrity and security of samples.

10

YES

Quality control procedures

5

YES

Study Implementation

10

YES

Specimen Management/ Maintenance

5

YES

Protocol Submissions and Adherence

  • Enter all existing and new study protocols into the Committee on Human Research (CHR) online system; seek assistance on maintaining all protocols in the system by communicating with CHR Analysts.
  • Design and enhance case report forms and data collection forms as needed; provide manuscript feedback; continue to develop and maintain systems for assuring protocol adherence and data quality.
  • Participate in the review and writing of protocols and related procedures to ensure institutional review board approval within University compliance.
  • Renew, modify, and submit CHR applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between CHR and study Investigators.
  • Provide quality assurance checks to note if protocols or UCSF CHR applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed.

5

YES

Regulatory responsibilities

  • Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
  • Initiate and follow-up on CHR submissions and modifications; track approval status.
  • Interface with departments to obtain UCSF approval prior to study initiation.
  • Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments.
  • Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.

Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation.

100%[MP3] [RR4]

(To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)

[MP1]Please indicate if this is an essential function (Y/N)

[RR2]Participation in regular team meetings is but training staff is not

[MP3]Please review the % to ensure they add to 100. Currently the total is 105%.

[RR4]This has been corrected


Required Qualifications

  • HS degree or equivalent and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
  • Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population.
  • Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
  • Excellent presentation skills; excellent organizational skills; and excellent interpersonal skills to work effectively in a diverse team.
  • Proficiency with Microsoft Word, Excel, PowerPoint, and Windows.
  • Excellent analytical and problem-solving skills.
  • Ability to work effectively in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects.
  • Ability to establish cooperative working relationships with patients, co-workers, & physicians.
  • Experience with geriatric, medical, or public health patient populations and proficiency in screening older adults for neuroimaging safety standards obtained through supervised experience.
  • Basic knowledge and proficiency with social science research design and statistical analyses.
  • Demonstrated proficiency in research interviewing using structured psychiatric instruments and disability measures obtained through supervised experience in older adult populations.
  • Demonstrated proficiency administering neuropsychological tests with older adult psychiatric populations obtained through supervised experience.
  • Recruitment experience and proficiency for older adult psychiatric patient populations

Preferred Qualifications

  • Bachelor’s Degree in Psychology or Neuroscience
  • Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system.
  • Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
  • Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
  • Experience with electronic medical records.
  • Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms.
  • Demonstrated proficiency with medical terminology.
  • Experience working with patients or study subjects.
  • Prior experience with use of neuropsychological, psychological and disability measures in older adults
  • Knowledge about and previous experience with mental health issues in older adults.
  • Knowledge of local mental health facilities and resources.
  • Knowledge of relevant literature regarding older adults, Hoarding Disorder, and Late Life Depression.
  • Clinical education/experience.
  • Experience with SPSS statistical package.
  • Experience with EndNote program
  • Knowledge of statistics
  • Experience scheduling neuroimaging scans and neuroimaging protocols
  • Experience applying the following regulations and guidelines:
    Good Clinical Practice Guidelines
    Health Information and Accountability Act (HIPAA)
    The Protection of Human Research Subjects
    CHR regulations for recruitment and consent of research subjects
    Effective Cash Handling Procedures
    Environmental Health and Safety Training
    Fire Safety Training

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